A core outcome set for the treatment of pregnant women with pregestational diabetes: an international consensus study

Oratile Kgosidialwa(Ollscoil na Gaillimhe – University of Galway), Delia Bogdanet(Ollscoil na Gaillimhe – University of Galway), Aoife M. Egan(Mayo Clinic in Arizona), Paula O’Shea(Ollscoil na Gaillimhe – University of Galway), Christine Newman(Ollscoil na Gaillimhe – University of Galway), Tomás P. Griffin(Ollscoil na Gaillimhe – University of Galway), C McDonagh(Ollscoil na Gaillimhe – University of Galway), C O'Shea(Ollscoil na Gaillimhe – University of Galway), Louise Carmody(Ollscoil na Gaillimhe – University of Galway), Shamil D. Cooray(Monash Health), E. Anastasiou(Mitera Hospital), Ewa Wender‐Ożegowska(Poznan University of Medical Sciences), Cheril Clarson(Western University), Alexandra Spadola(Tufts Medical Center), Fernanda Alvarado(Tufts Medical Center), Eoin Noctor(University Hospital Limerick), Eugene Dempsey(University College Cork), Angela Napoli(Azienda Ospedaliera Sant'Andrea), Caroline A Crowther(University of Auckland), Sander Galjaard(Erasmus MC), Mary R. Loeken(Joslin Diabetes Center), M. Maresh(Manchester Academic Health Science Centre), Paddy Gillespie(National University of Ireland), Harold de Valk(University Medical Center Utrecht), Andrea Agostini(Energias de Portugal (Portugal)), Linda Biesty(Ollscoil na Gaillimhe – University of Galway), Declan Devane(Ollscoil na Gaillimhe – University of Galway), Fidelma Dunne(Ollscoil na Gaillimhe – University of Galway)
BJOG An International Journal of Obstetrics & Gynaecology
July 4, 2021
10.1111/1471-0528.16825
Cited by 31Open Access
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Abstract

OBJECTIVE: To develop a core outcome set (COS) for randomised controlled trials (RCTs) evaluating the effectiveness of interventions for the treatment of pregnant women with pregestational diabetes mellitus (PGDM). DESIGN: A consensus developmental study. SETTING: International. POPULATION: Two hundred and five stakeholders completed the first round. METHODS: The study consisted of three components. (1) A systematic review of the literature to produce a list of outcomes reported in RCTs assessing the effectiveness of interventions for the treatment of pregnant women with PGDM. (2) A three-round, online eDelphi survey to prioritise these outcomes by international stakeholders (including healthcare professionals, researchers and women with PGDM). (3) A consensus meeting where stakeholders from each group decided on the final COS. MAIN OUTCOME MEASURES: All outcomes were extracted from the literature. RESULTS: We extracted 131 unique outcomes from 67 records meeting the full inclusion criteria. Of the 205 stakeholders who completed the first round, 174/205 (85%) and 165/174 (95%) completed rounds 2 and 3, respectively. Participants at the subsequent consensus meeting chose 19 outcomes for inclusion into the COS: trimester-specific haemoglobin A1c, maternal weight gain during pregnancy, severe maternal hypoglycaemia, diabetic ketoacidosis, miscarriage, pregnancy-induced hypertension, pre-eclampsia, maternal death, birthweight, large for gestational age, small for gestational age, gestational age at birth, preterm birth, mode of birth, shoulder dystocia, neonatal hypoglycaemia, congenital malformations, stillbirth and neonatal death. CONCLUSIONS: This COS will enable better comparison between RCTs to produce robust evidence synthesis, improve trial reporting and optimise research efficiency in studies assessing treatment of pregnant women with PGDM. TWEETABLE ABSTRACT: 165 key stakeholders have developed #Treatment #CoreOutcomes in pregnant women with #diabetes existing before pregnancy.

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